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Implications of in-use photostability: proposed guidance for photostability testing and labeling to support the administration of photosensitive pharmaceutical products, part 1: drug products…
- S. Baertschi, D. Clapham, H. Tønnesen
- Political ScienceJournal of pharmaceutical sciences
- 1 November 2013
This commentary suggests a systematic approach, based on realistic "worst case" photoexposure scenarios and the existing ICH Option 1 and 2 light sources, to provide valuable data to pharmaceutical manufacturers and compounding pharmacists for the safe and effective use of photosensitive injection products.
Characterization of impurities formed by interaction of duloxetine HCl with enteric polymers hydroxypropyl methylcellulose acetate succinate and hydroxypropyl methylcellulose phthalate.
- P. Jansen, P. Oren, C. A. Kemp, S. Maple, S. Baertschi
- Chemistry, Materials ScienceJournal of pharmaceutical sciences
It is proposed that polymer-bound succinic and phthalic substituents can be cleaved from the polymer, resulting in the formation of either the free acids or the anhydrides, enabling the reaction to be enabled by migration of the free acid or anhydride through the formulation.
The degradation of the antitumor agent gemcitabine hydrochloride in an acidic aqueous solution at pH 3.2 and identification of degradation products.
Only one of these degradation products, the uridine analogue of gem citabine, was a known degradation product of gemcitabine and was identified by comparison with synthesized material, and the mechanisms of formation are discussed.
Isolation, identification, and synthesis of two oxidative degradation products of olanzapine (LY170053) in solid oral formulations.
Two impurities found in both stressed and aged solid-state formulations of olanzapine have been identified as…
Determination of the Degradation Chemistry of the Antitumor Agent Pemetrexed Disodium.
Role of ‘‘mass balance’’ in pharmaceutical stress testing
Determination of relative UV response factors for HPLC by use of a chemiluminescent nitrogen-specific detector.
Stress Testing: A Predictive Tool
Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2: Safety Considerations of Impurities in Pharmaceutical…
This article summarizes sessions 3 and 4 of the American Association for Pharmaceutical Scientists (AAPS) Workshop on Predicting and Monitoring Impurities in API and Drug Products and addresses issues of safety considerations of impurities in pharmaceutical products and surveying the impurity landscape.
Assessing the Risk of Formation of Potential Genotoxic Degradation Products in a Small-Molecule Kinase Inhibitor Drug Substance and Drug Product
Galunisertib is a kinase inhibitor designed to selectively inhibit TGF-β signaling that generated positive alerts for mutagenicity by in silico structure–activity relationship-based genotoxicity assessment and both tested positive in the Ames bacterial mutagicity test.